Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)

NCT ID: NCT03253796

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2021-03-17

Brief Summary

The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

Conditions

Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GLM SC QM (Full Treatment Regimen)

Period 1: participants are treated with open-label (OL) GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded SC GLM QM for up to 12 months

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: BIOLOGICAL

Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.

GLM SC Q2M (Reduced Treatment Regimen)

Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded GLM SC every other month alternating with matching placebo to GLM every other month for up to 12 months

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: BIOLOGICAL

Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.

Placebo

Intervention Type: BIOLOGICAL

Injections of matching placebo for golimumab.

Placebo (Treatment Withdrawal Regimen)

Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded placebo for up to 12 months

Group Type: PLACEBO_COMPARATOR

Golimumab

Intervention Type: BIOLOGICAL

Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.

Placebo

Intervention Type: BIOLOGICAL

Injections of matching placebo for golimumab.

OL GLM Retreatment

Participants who experience a disease flare during double-blinded treatment in Period 2 will discontinue blinded treatment and receive OL GLM SC QM.

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: BIOLOGICAL

Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.

Interventions

Golimumab

Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.

Intervention Type: BIOLOGICAL

Placebo

Injections of matching placebo for golimumab.

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-8259; Simponi®

Eligibility Criteria

Inclusion Criteria

• Is not of reproductive potential, or is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication
• Has chronic back pain of ≥3 months duration by history
• Has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axSpA) with disease duration <= 5 years
• Meets one of the following criteria:

1. Has active inflammation on magnetic resonance imaging (MRI) highly suggestive of sacroiliitis associated with spondyloarthropathy and 1 or more of the following spondyloarthritis (SpA) characteristics:

• Inflammatory back pain
• Arthritis (physician-diagnosed)
• Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
• Dactylitis (physician-diagnosed)
• Psoriasis (physician-diagnosed)
• History of physician-diagnosed inflammatory bowel disease (IBD)
• History of uveitis confirmed by an ophthalmologist
• Good response to nonsteroidal anti-inflammatory drugs (NSAID)
• Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)
• Elevated C-reactive protein (CRP)

• Human leukocyte antigen B27 (HLA-B27)+ gene OR

2. Has a HLA-B27+ gene and 2 or more of the following SpA characteristics:

• Inflammatory back pain
• Arthritis (physician-diagnosed)
• Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
• Dactylitis (physician-diagnosed)
• Psoriasis (physician-diagnosed)
• History of physician-diagnosed inflammatory bowel disease (IBD)
• History of uveitis confirmed by an ophthalmologist
• Good response to nonsteroidal anti-inflammatory drugs (NSAID)
• Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)
• Elevated C-reactive protein (CRP)
• Has elevated CRP at Screening or evidence of active inflammation in the sacroiliac joints on MRI
• Has an Ankylosing Spondylitis Disease Activity Score (ASDAS) >= 2.1 at Screening
• Shows high disease activity at Screening and Baseline of both a Total Back Pain score of ≥4 and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4
• Has an acceptable history of NSAID use
• Has no history of untreated latent or active tuberculosis (TB) prior to Screening
• Has had no recent close contact with a person with active TB or, if there has been such contact, will undergo additional evaluations and receive appropriate treatment for latent TB
• Agrees to undergo screening for hepatitis B virus (HBV) and demonstrates negative results for hepatitis B surface antigen (HBsAg) and HBV deoxyribonucleic acid (DNA)

Exclusion Criteria

• Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays
• Is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication
• Intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication
• Has any clinically significant condition or situation that would interfere with the trial evaluations or participation in the trial
• Has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
• Has received any treatment listed below more recently than the indicated off-drug period prior to Screening

• • Disease-modifying anti-rheumatic drugs (30 days off drug)
• • Live vaccinations (3 months off drug)
• • Investigational medications (30 days or 5 half-lives off drug, whichever is longer)
• • Bacille Calmette-Guerin (BCG) vaccination (12 months off drug)
• Has any systemic inflammatory condition, including psoriatic arthritis, active Lyme disease, systemic lupus erythematosus, infectious arthritis, vasculitis, parvovirus infection, rheumatoid arthritis, active uveitis, or active IBD
• Has a history of latent or active granulomatous infection prior to Screening
• Had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to Screening
• Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
• Had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to Baseline
• Had a history of, or ongoing, chronic or recurrent infectious disease
• Is known to be infected with human immunodeficiency virus (HIV) or seropositive for hepatitis C virus (HCV)
• Has had a chest x-ray within 2 months prior to Screening that shows an abnormality suggestive of a current active infection or malignancy
• Has a history of lymphoproliferative disease
• Has had a malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of cervix that has been surgically cured)
• Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
• Has a history of or concurrent congestive heart failure of any grade
• Has a transplanted organ (with the exception of a corneal transplant performed >= 3 months prior to baseline)
• Has current signs or symptoms of significant medical illness which could interfere with the trial, or require treatment that might interfere with the trial
• Is a user of recreational or illicit drugs or has or had a substance abuse (drug or alcohol) problem within the previous 2 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

FN Brno ( Site 0005)

Brno, , Czechia

Revmatologie s.r.o. ( Site 0009)

Brno, , Czechia

CCBR Ostrava s.r.o. ( Site 0001)

Ostrava, , Czechia

Artroscan s.r.o. ( Site 0007)

Ostrava-Trebovice, , Czechia

CCR Czech a.s. ( Site 0003)

Pardubice, , Czechia

CCR Prague s.r.o ( Site 0004)

Prague, , Czechia

Fakultni nemocnice v Motole ( Site 0127)

Prague, , Czechia

Medical Plus s.r.o ( Site 0010)

Uherské Hradiště, , Czechia

PV - Medical s.r.o. ( Site 0006)

Zlín, , Czechia

Universitaetsklinik der Charite Berlin ( Site 0023)

Berlin, , Germany

U. klinikum Koeln AOER ( Site 0025)

Cologne, , Germany

Rheumazentrum Ruhrgebiet ( Site 0021)

Herne, , Germany

Klinikum der Universitaet Muenchen - LMU ( Site 0026)

München, , Germany

Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)

München, , Germany

Antonius Ziekenhuis Sneek ( Site 0043)

Sneek, Provincie Friesland, Netherlands

Vrij Universiteit Medisch Centrum ( Site 0044)

Amsterdam, , Netherlands

Leids Universitair Medisch Centrum ( Site 0041)

Leiden, , Netherlands

Maasstad Ziekenhuis ( Site 0042)

Rotterdam, , Netherlands

Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060)

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne Pratia Katowice ( Site 0059)

Katowice, Silesian Voivodeship, Poland

NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058)

Bialystok, , Poland

Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)

Bydgoszcz, , Poland

Centrum Kliniczno-Badawcze ( Site 0152)

Elblag, , Poland

Krakow Medical Centre ( Site 0052)

Krakow, , Poland

NZOZ Reumed ( Site 0051)

Lublin, , Poland

Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057)

Sopot, , Poland

Lubelskie Centrum Diagnostyczne ( Site 0053)

Świdnik, , Poland

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)

Torun, , Poland

Reumatika ( Site 0055)

Warsaw, , Poland

Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177)

Brasov, , Romania

Clinical Hospital Ioan Cantacuzino ( Site 0184)

Bucaresti, , Romania

SC Duo Medical SRL ( Site 0183)

Bucharest, , Romania

Spitalul Clinic Sfanta Maria ( Site 0182)

Bucharest, , Romania

Colentina Clinical Hospital ( Site 0231)

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176)

Cluj-Napoca, , Romania

RKMed Center ( Site 0180)

Iași, , Romania

S.C.Pelican Impex S.R.L ( Site 0232)

Oradea, , Romania

Covamed Serv SRL ( Site 0178)

Sfântu Gheorghe, , Romania

Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179)

Timișoara, , Romania

GUZ Regional Clinical Hospital ( Site 0076)

Saratov, Oktyabrskiy Region, Russia

Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061)

Moscow, , Russia

SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)

Saint Petersburg, , Russia

SBHI Leningrad Regional Clinical Hospital ( Site 0065)

Saint Petersburg, , Russia

LLC Sanavita ( Site 0074)

Saint Petersburg, , Russia

Tolyatti City Clinical Hospital 5 ( Site 0069)

Tolyatti, , Russia

Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075)

Yaroslavl, , Russia

Hospital de Basurto ( Site 0082)

Bilbao, , Spain

Hospital Universitario Reina Sofia ( Site 0081)

Córdoba, , Spain

Hospital Universitario La Paz ( Site 0083)

Madrid, , Spain

Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)

Murcia, , Spain

Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)

Antalya, Ankara, Turkey (Türkiye)

Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)

Ankara, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)

Ankara, , Turkey (Türkiye)

Ankara Universitesi Tıp Fakultesi ( Site 0093)

Ankara, , Turkey (Türkiye)

Pamukkale Unv. Tip Fak. ( Site 0097)

Denizli, , Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)

Istanbul, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)

Kocaeli, , Turkey (Türkiye)

Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)

Cherkassy, , Ukraine

MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)

Dnipropetrovsk, , Ukraine

SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261)

Kharkiv, , Ukraine

ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262)

Kharkiv, , Ukraine

Kyivska miska klinichna likarnia N3 ( Site 0266)

Kyiv, , Ukraine

M. D. Strazhesko Institute of Cardiology. ( Site 0264)

Kyiv, , Ukraine

Medical Center Ibn Sina ( Site 0268)

Kyiv, , Ukraine

Clinic of Modern Rheumatology ( Site 0265)

Kyiv, , Ukraine

Communal City Clinical Hospital #4 ( Site 0230)

Lviv, , Ukraine

MI Odesa Regional Clinical Hospital ( Site 0226)

Odesa, , Ukraine

M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224)

Poltava, , Ukraine

Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225)

Vinnutsya, , Ukraine

SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263)

Vinnytsia, , Ukraine

Zaporizhzha Regional Clinical Hospital ( Site 0223)

Zaporizhzhya, , Ukraine

Countries

Czechia; Germany; Netherlands; Poland; Romania; Russia; Spain; Turkey (Türkiye); Ukraine

References

Weinstein CLJ, Sliwinska-Stanczyk P, Hala T, Stanislav M, Tzontcheva A, Yao R, Berd Y, Curtis SP, Philip G. Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumatology (Oxford). 2023 Nov 2;62(11):3601-3609. doi: 10.1093/rheumatology/kead112.

Reference Type: RESULT

PMID: 36919768 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-8259-038

Identifier Type: OTHER

Identifier Source: secondary_id

2015-004020-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8259-038

Identifier Type: -

Identifier Source: org_study_id